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The purpose of this study is to characterize the effect of HDM1002 on the PK of single dose of repaglinide, atorvastatin, digoxin and rosuvastatin in healthy adult subjects. The safety and tolerability of HDM1002 with repaglinide, atorvastatin, digoxin and rosuvastatin when given separately or together will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDM1002 with Repaglinide, Atorvastatin, Digoxin and Rosuvastatin | Experimental | Period 1: Single dose of repaglinide, atorvastatin, digoxin and rosuvastatin Period 2: Once daily dose of HDM1002 Period 3: Single dose of repaglinide, atorvastatin, digoxin and rosuvastatin with once daily dose of HDM1002 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repaglinide | Drug | Single dose; Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC[0-∞] | Pharmacokinetics (PK) parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Area under the curve from time 0 hour to ∞ | Period 1 and Period 3: Day 1-Day 16 |
| AUC[0-t] | PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Area under the curve from time 0 to t hour | Period 1 and Period 3: Day 1-Day 16 |
| Cmax | PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Maximum observed concentration | Period 1 and Period 3: Day 1-Day 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Time to maximum plasma concentration | Period 1 and Period 3: Day 1-Day 16 |
| t1/2 | PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Half life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheng Cui | Contact | +86-010 82266455 | cuicheng1226@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | China |
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| Atorvastatin | Drug | Single dose; Administered orally |
|
| Digoxin | Drug | Single dose; Administered orally |
|
| Rosuvastatin | Drug | Single dose; Administered orally |
|
| HDM1002 | Drug | Administered orally |
|
| Period 1 and Period 3: Day 1-Day 16 |
| CL/F | PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Apparent Clearance | Period 1 and Period 3: Day 1-Day 16 |
| Vz/F | PK parameter of repaglinide, atorvastatin, digoxin and rosuvastatin: Apparent volume of distribution | Period 1 and Period 3: Day 1-Day 16 |
| Adverse events (AEs) | Number of subjects reporting AEs | Period 1 and Period 3: Day 1-Day 16, Period 2: Day 1-Day 35 |
| ID | Term |
|---|---|
| C072379 | repaglinide |
| D000069059 | Atorvastatin |
| D004077 | Digoxin |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
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